A little-known federal agency is considering altering the label on a common pill to explain to women the possible risks of using estrogen-replacement therapy (ERTA), a controversial form of hair loss medication.
The U.S. Food and Drug Administration (FDA) is looking into the changes, which would be the latest in a string of changes that could potentially affect the health and well-being of millions of women.
“We have looked at it as part of our oversight responsibilities,” said Julie Smith, a FDA spokeswoman.
The agency has not yet finalized the changes and it will likely take at least six months before the agency issues a final rule, Smith said.
The FDA has been reviewing a list of drugs that can be prescribed to women to see if they are likely to cause hair loss.
A recent review by the agency concluded that the medications used in ERTA are not likely to increase the risk of hair growth, but the agency is still weighing the merits of their benefits and potential risks.
Some women who take ERTA say it is helpful for women with moderate to severe acne, as well as in cases of severe psoriasis.
“It’s not as effective as other therapies for psorosis and the treatment itself isn’t very effective, so the question is, ‘Is it worth the cost?'” said Kimberly Johnson, an esthetician at St. Luke’s Hospital in Philadelphia, Pennsylvania, who has tried ERTA and is a patient of Dr. Maryann Reiss, an ERTA user.
“The FDA has looked at what other studies have shown and the results are overwhelmingly negative,” Johnson said.
“They have not been able to demonstrate that there is a clear benefit to the use of ERTA.”
ERTA has been prescribed for many years to treat moderate-to-severe cases of psorias.
Dr. Reiss’s prescribing guidelines state that the drugs can be used by women who do not have other health problems, who have a history of acne or have mild to moderate acne.
The guidelines also state that women should not use more than 20 to 30 milligrams of ERSA per day.
The new labeling is the latest step by the FDA in trying to determine the benefits and risks of the medications.
Before the agency made its changes in 2016, women could still get the pills without the labels.
“I’m not going to lie to you,” said Jennifer Johnson, a 30-year-old nurse in Florida.
“People need to know the risks.
But for some women, it can be helpful.”
The FDA also is examining a separate drug, N-acetylcysteine (NAC), that is being tested by researchers in Europe.
The drugs are being studied to see how well they work in treating psoroid and mild-to moderate psorotic facial disorders.
Some doctors and researchers have expressed concern that the medication may not work for people who have had severe facial psoritis, including psoracea sufferers.
“NAC is being studied because it has been shown to work for psorsus,” said Dr. Robert Wolkowitz, a dermatologist at the University of Chicago School of Medicine.
“If it does work, it will be a tremendous benefit for psoricidics who do suffer from facial psorsiasis.
The cost is minimal and it works.”
Women who take NAC are being encouraged to use the medication, which is approved by the U.K. to treat severe psoriatic and mild psoroidal conditions.
“A few people are going to need to be more cautious,” said Johnson.
“Some people might not like the pill, but if it is effective for them, then they might consider taking it.
It is a drug of choice.”
Experts say the new FDA labeling would be good for women who are trying to get their hair back, and that women who use ERTA should not hesitate to start taking it if they feel they need to.
“Women who take these medications for facial psores should be cautious and follow their doctor’s instructions to avoid side effects,” said Reiss.
“You need to understand the risks and benefits.”
The new FDA guidelines also include a new warning about the use by women with certain other conditions.
If a woman with a history or physical condition that causes hair loss develops hair loss after starting a new ERTA dose, the label will warn that the drug may not be effective for this patient.
In other words, if the woman is taking ERTA because she has a condition that is a contributing factor to hair loss but does not require treatment, she should start the drug with caution and get her hair back.
“There are some women who have not responded to the warnings for the treatment of other medical conditions,” said Wolkowski.
“So, if that is the case, we will continue to monitor this patient closely